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Diabetic Drug Invokana

U.s. Fda Approves Invokana™ (canagliflozin) For The Treatment Of Adults With Type 2 Diabetes

U.s. Fda Approves Invokana™ (canagliflozin) For The Treatment Of Adults With Type 2 Diabetes

INVOKANA™ is the first in a new class of type 2 diabetes medications available in the United States In Phase 3 studies, INVOKANA™ improved blood glucose control and was associated with reductions in body weight and systolic blood pressure Janssen will partner with other Johnson & Johnson companies focused on diabetes to bring INVOKANA™ to healthcare professionals “Patients with type 2 diabetes struggle managing their blood sugar, and nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, increasing their risks for potentially life-threatening complications,” said Richard Aguilar*, M.D., Medical Director, Diabetes Nation, LLC and Diabetes Care Foundation, a non-profit organization committed to improving diabetes care. "INVOKANA™ is thought to work differently than other currently-available medicines because it reduces blood glucose by acting on the kidneys as a ‘glucuretic,’ increasing the loss of glucose in the urine. What has historically been viewed as a sign of diabetes – glucose in the urine – may also reflect the efficacy of a new and unique approach to treatment.” The kidneys make an important contribution to balancing blood glucose. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An important carrier responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2). INVOKANA™ selectively inhibits SGLT2, and as a result promotes the loss of glucose in the urine, lowering blood glucose levels in adults with type 2 diabetes. “INVOKANA™ provides patients with type 2 diabetes the option of a once-daily oral therapy that offers improved glycemic control and, in Phase 3 studies, showed an incidence of hypoglycemia – low blood Continue reading >>

Diabetes Drug Invokana And Amputation Risk

Diabetes Drug Invokana And Amputation Risk

The U.S. Food and Drug Administration (FDA) informed manufacturing giant Johnson & Johnson in May, 2017 that they must put new warning labels on diabetes drug, Invokana (generic, canagliflozin), and its variations, Invokamet and Invokamet XR. The new warning is to alert the consumer to the clinical study findings that taking the diabetes drug can put them at double the risk of amputation of the leg and/or foot. The clinical studies, CANVAS and CANVAS-R were studies done by Johnson & Johnson that the manufacturer was counting on to show that Invokana was safe. The opposite was true and the drug had already had a past reputation for its side effects of diabetic ketoacidosis, bone fractures, heart attacks, strokes, in addition to the increased risk of amputations. For consumers taking Invokana, the FDA warns to look out for pain/tenderness, sores, ulcers, or infections in the leg and feet that are new since taking the drug. These conditions bring a much more significant chance of partial or total amputation and must be monitored carefully. If you or a loved one has been negatively impacted by Invokana, Invokamet, or Invokamet XR (or the generic form, canagliflozin), or other medical device, drug, or products, consult your medical provider and do not hesitate to contactInserra Kelley Sewell, Personal Injury Attorneys, to discuss your possible claim and entitlement to compensation for your damages. To learn more, visit: When it Comes to Invokana Diabetic Drug Lawsuits, We’re Fighting for Nebraskan’s Rights Continue reading >>

Sglt2 Inhibitors: A New Class Of Diabetes Medications

Sglt2 Inhibitors: A New Class Of Diabetes Medications

Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new class of diabetic medications indicated only for the treatment of type 2 diabetes. In conjunction with exercise and a healthy diet, they can improve glycemic control. They have been studied alone and with other medications including metformin, sulfonylureas, nizagara 100, pioglitazone, and insulin. Editor’s Note: Since we first looked at this new drug class in April 2013, numerous studies have been done on the benefits and risks of the SGLT2 inhibitors. See below for a roundup of the new information, including the latest investigational drug in this class, Ertugliflozin. How SGLT2 Inhibitors Work SGLT2 is a protein in humans that facilitates glucose reabsorption in the kidney. SGLT2 inhibitors block the reabsorption of glucose in the kidney, increase glucose excretion, and lower blood glucose levels. SGLT2 is a low-affinity, high capacity glucose transporter located in the proximal tubule in the kidneys. It is responsible for 90% of glucose reabsorption. Inhibition of SGLT2 leads to the decrease in blood glucose due to the increase in renal glucose excretion. The mechanism of action of this new class of drugs also offers further glucose control by allowing increased insulin sensitivity and uptake of glucose in the muscle cells, decreased gluconeogenesis and improved first phase insulin release from the beta cells. It is proposed that in prehistoric times, we developed an elegant system for maximizing energy conservation and storage, due to lack of consistent food supplies. This system included reducing the activity of our neurological endocrine system to slow metabolism and conserve the stored energy in our bodies, as well as a method to increase reabsorption of excess glucose that was removed by the kidneys Continue reading >>

F.d.a. Approves A New Diabetes Drug From J.&j.

F.d.a. Approves A New Diabetes Drug From J.&j.

The Food and Drug Administration on Friday approved the first of a new class of medicines to treat diabetes. The drug, Invokana, will be sold by Johnson & Johnson and treats patients with type 2 diabetes in a new way, by causing blood sugar to be excreted in the urine. Many existing drugs work by affecting the supply or use of insulin. “We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions,” Dr. Mary Parks, who oversees drugs for metabolic diseases at the F.D.A., said in a statement. Invokana will have a wholesale price of $8.77 per tablet, with one tablet taken daily. Johnson & Johnson said the price was competitive with that of some other diabetes drugs. Clinical trials of more than 10,000 patients showed that Invokana improved patients’ blood-sugar levels and also led to weight loss and reductions in blood pressure. But the drug, whose generic name is canagliflozin, also has potentially serious side effects. The clinical trials revealed some signs of elevated stroke risk and a small increase in patients’ experiencing heart attacks within the first 30 days of taking the medicine. The drug also was shown to raise LDL, or “bad” cholesterol levels, although it also raised the level of HDL, or “good” cholesterol. However, an F.D.A. spokeswoman said Friday that the significance of those findings was unclear, and the label of the drug includes no warnings about heart attacks or strokes. The F.D.A. is requiring Johnson & Johnson to conduct five post-marketing studies, including a clinical trial to determine more definitively if the drug increases those risks. The F.D.A. said the drug’s most common side effects were vaginal yeast infections and urinary tract infections. In Jan Continue reading >>

Search Delicious, Diabetes-friendly Recipes

Search Delicious, Diabetes-friendly Recipes

INVOKANA® can cause important side effects, including: Amputations. INVOKANA® may increase your risk of lower-limb amputations. Amputations mainly involve removal of the toe or part of the foot; however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation, some on both sides of the body. You may be at a higher risk of lower-limb amputation if you: have a history of amputation, have heart disease or are at risk for heart disease, have had blocked or narrowed blood vessels (usually in leg), have damage to the nerves (neuropathy) in the leg, or have had diabetic foot ulcers or sores. Call your doctor right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Your doctor may decide to stop your INVOKANA® for a while if you have any of these signs or symptoms. Talk to your doctor about proper foot care Dehydration. INVOKANA® can cause some people to become dehydrated (the loss of too much body water), which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure (including diuretics [water pills]), are on a low sodium (salt) diet, have kidney problems, or are 65 years of age or older Vaginal yeast infection. Women who take INVOKANA® may get vaginal yeast infections. Symptoms include: vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching Yeast infection of the penis (balanitis or balanoposthitis). Men who take INVOKANA® may get a yeast infection of the skin around the penis. Symptoms include: redness, itching, or swelling o Continue reading >>

Studies Show Diabetes Drug Invokana Increases Amputation Risk

Studies Show Diabetes Drug Invokana Increases Amputation Risk

People with diabetes who take a class of drugs known as sodium–glucose cotransporter 2 (SGLT2) inhibitors will now need to weigh benefits against risks after studies showed the medications significantly reduce heart problems in subjects, but, surprisingly, also increase the risk of amputation. The results of the studies on the Johnson & Johnson drug canagliflozin, marketed under the name Invokana, confirm cardiovascular benefits not only for that particular medication, but also for others in its class. Those same results, however, call into question whether other drugs in the class also contribute to increased amputation. “Drugs to treat diabetes have been undergoing a positive transformation in the last three or four years,” says Dr. Bruce Neal, lead investigator in the study and professor of medicine for University of New South Wales Sydney, and senior director, the George Institute for Global Health in Sydney, Australia. “It used to be we would test diabetes drugs to see if they lowered glucose levels and did not cause heart problems. Now, we test drugs and expect to see them not only lower glucose but improve cardiovascular health. It’s been extraordinary. But, now we might be finding out that there are glitches along the way.” Neal led a team of six other academic researchers combining data from two studies, the first a clinical trial before the drug was approved by the Food and Drug Administration in 2013 and the second a post-marketing study designed to detect any cardiovascular risks from the drug. Such studies are a recent requirement of the FDA to ensure safety of new medications across a wider population than may have been tested in clinical trials for the drug’s initial approval. The studies, one called Canagliflozin Cardiovascular Assessment S Continue reading >>

Diabetes Drug Invokana Must Warn Patients About Increased Risk Of Foot, Leg Amputation

Diabetes Drug Invokana Must Warn Patients About Increased Risk Of Foot, Leg Amputation

A new class of diabetes medicines is heavily advertised on TV and shows great promise in getting patients’ blood sugar levels down, but a safety announcement from the Food and Drug Administration warns that one of the drugs, Johnson & Johnson’s Invokana, doubles those patients’ chance of needing parts of their legs or feet amputated. People with diabetes are already at risk of having lower limbs amputated because of circulatory and nerve damage that the disease does over time. However, in two clinical trials of the drug canagliflozin, marketed as Invokana, Invokamet, and Invokamet XR, patients taking the drug were twice as likely to need amputations. Most of the amputations were of toes or the middle of the foot, but some patients needed their entire foot or leg removed, sometimes even above the knee. The two studies lasted a year. In one, which had 4,330 patients enrolled, 5.9 out of 1,000 patients treated with the drug needed amputations, compared to 2.8 out of 1,000 patients receiving a placebo. In the other, which enrolled 5,814 patients, 7.5 out of 1,000 patients receiving canagliflozin had a foot or leg amputation that year, compared to 4.2 out of 1,000 of the patients receiving a placebo. Due to these results, the FDA will require new warnings on Invokana, including the attention-getting boxed warning. It will alert patients to be watchful and notify health care providers about ulcers, infections, or any new pain or tenderness in their legs and feet. Physicians will be warned to consider an individual patient’s risk when deciding whether to prescribe the medication, including their past foot or toe amputations and history of diabetic ulcers, vascular disease, or nerve damage. Discovering serious risks from taking a drug after it’s been on the market isn Continue reading >>

Invokana: Diabetes Drug Gets Black Box Warning For Amputation Risks

Invokana: Diabetes Drug Gets Black Box Warning For Amputation Risks

Invokana (canagliflozin), an SGLT-2 drug for use in type 2 diabetes and off-label in those with type 1 diabetes has been required by the FDA to carry the prominent boxed warning due to a higher risk for leg and foot amputations. This new requirement is a result of two clinical trials whose data revealed these elevated risks. Canagliflozin is the drug present in the marketed products: Invokana, Invokamet, and Invokamet XR. The clinical trials called CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) revealed that leg and foot amputations happened about twice as often in those taking canagliflozin compared to those taking a placebo. Over the span of a year the amputation risk for CANVAS trial patients was equal to 5.9 out of every 1,000 patients taking canagliflozin and 2.8 out of every 1,000 patients taking a placebo. Over the span of a year the amputation risk for CANVAS-R trial patients was equal to 7.5 out of every 1,000 patients taking canagliflozin and 4.2 out of every 1,000 patients taking a placebo. Most common was toe and middle the foot amputations but below and above the knee leg amputations were also observed. Some patients needed multiple amputations, “some involving both limbs.” This warning is in addition to last year’s FDA strengthened warning to users of canagliflozin for an increased risk of acute kidney injury and in 2015 the strengthened “warning for canagliflozin related to the increased risk of bone fractures,” Symptoms to Watch For The FDA warns that if you take Invokana (canagliflozin) you should be sure to call your healthcare provider immediately if you “develop new pain or tenderness, sores or ulcers, or i Continue reading >>

Sglt2 Inhibitors, Farxiga, Invokana, Jardiance. Dangerous New Drugs

Sglt2 Inhibitors, Farxiga, Invokana, Jardiance. Dangerous New Drugs

The FDA recently gave its approval to several new drugs that are part of a new class of diabetes drugs, the SGLT2 inhibitors. All have very troubling side effects. More are awaiting approval. The first of these was Johnson & Johnson's drug canagliflozin, which is marketed in the U.S. as Invokana. It is also sold in a combination pill containing metformin as Invokamet. These sodium-glucose co-transporter-2 (SGLT-2) inhibitors lower blood sugar by blocking reabsorption of glucose by the kidney and increasing its excretion in urine. However, recent findings suggest that though these drugs increase excretion of glucose, they simultaneously increase the production of glucose by stimulating the secretion of glucagon. More about that can be read HERE. The manufacturers also claim that they cause weight loss--always a potent selling point for a diabetes drug. Most recently, a questionable research study has been the basis of the claim that one of these drugs actually prevents heart attacks. The facts are quite different, but drug company flacks are saturation bombing family physicians with materials that make it sound like they should put every patient with Type 2 on this wonderful, new drug, which is priced at $8.77 a pill or $263.10 for a monthly supply. They shouldn't. When the first of these drugs, Invokana (canagliflozin), came up for approval, the committee of "experts" who reviewed it were ambivalent about it because the company's own, [most likely, statistically manipulated], clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients taking canagliflozin suffered a major cardiovascular event [mainly strokes and some heart attacks] compared with just one patient taking a placebo. After that, the imbalanc Continue reading >>

Fda Adds

Fda Adds "black Box" Warning To Popular Diabetes Drug Invokana

Following months of review of anecdotal and statistical evidence, the U.S. Food and Drug Administration has recently strengthened warnings on the packaging of one of the most popular drugs for the treatment of Type 2 diabetes. The medicine, canagliflozin is sold under the brand names Invokana, Invokamet and Invokamet XR. In theory, the medication helps diabetes patients better manage their insulin and blood sugar levels. In addition, it should prevent internal damage from diabetes symptoms. The medication was introduced for sale in 2013 and quickly became one of the most popular diabetes drugs on the market. Countless patients have taken Invokana since then in order to: Control blood sugar; Lower A1C levels; Prevent kidney damage often associated with diabetes; and Lower the risk of amputation caused by diabetes. (In some people, uncontrolled diabetes can cause circulatory issues, leading to infections, lack of blood flow, nerve damage and more.) Tragically, the very same drug that should have lowered patients' risk of diabetes-associated amputations may have caused them. Two large-scale clinical trials reviewed by the FDA in 2016 showed that people taking Invokana suffered amputations at nearly twice the rate of people given a placebo. The FDA advises that medical professionals use caution when prescribing Invokana, particularly if patients have risk factors for amputation. These include: History of prior amputation of limbs or digits; Vascular disease; Neuropathy; Diabetic-related foot ulcers; Delayed healing of wounds, particularly in the lower extremities; and Other serious diabetes-associated conditions (blindness, nerve damage, kidney damage, or heart disease). Were you prescribed Invokana to manage your Type 2 diabetes and suffered an amputation as a result? Or m Continue reading >>

Invokana (canagliflozin) For The Treatment Of Type 2 Diabetes

Invokana (canagliflozin) For The Treatment Of Type 2 Diabetes

Invokana is available in 100mg and 300mg doses for oral administration. Image courtesy of Janssen Pharmaceuticals. Invokana is indicated for the treatment of type 2 diabetes. Image courtesy of Janssen Pharmaceuticals. Invokana (canagliflozin) is indicated to improve glycemic control in adults with type 2 diabetes, along with diet and exercise. It was first developed by Mitsubishi Tanabe Pharma Corporation in Japan and later licensed to Janssen Pharmaceuticals. In March 2013, Invokana received approval from the US Food and Drug Administration (FDA) for the treatment of adults with type 2 diabetes. Type 2 diabetes symptoms "In March 2013, Invokana received approval from the US Food and Drug Administration (FDA) for the treatment of adults with type 2 diabetes." Type 2 diabetes mellitus is a metabolic disorder in which the body does not produce enough insulin and / or the cells of the body do not respond adequately to it. It is characterised by high levels of sugar in the blood. Some of the symptoms of the disease include frequent urination, constant appetite and excess thirst. According to the US Centers for Disease Control and Prevention, about 26m people in the US are affected by diabetes. It is also found that about 60% of type 2 diabetes patients are obese and about 30% are overweight. Obesity can make body cells resist the action of insulin. Invokana mechanism of action Invokana is the first in a new class of drugs, called sodium glucose co-transporter 2 (SGLT2) inhibitors, to be approved in the United States. SGLT2 reabsorbs glucose filtered from the blood into the kidneys. By inhibiting SGLT2, Invokana acts as a ‘glucuretic’, promoting the emission of glucose in the urine and reducing blood glucose levels. The drug is available in 100mg and 300mg dose tablets f Continue reading >>

Invokana Lawsuit - Ketoacidosis & Kidney Injuries

Invokana Lawsuit - Ketoacidosis & Kidney Injuries

About Invokana and SGLT2 Inhibitors The first SGLT2 inhibitor to be cleared for use in the U.S. was Invokana in 2012. SGLT2 inhibitors work differently than other diabetes medications as they don’t actually affect insulin levels. Instead, they limit the reabsorption of glucose in the kidneys to help reduce the amount of sugar in the bloodstream. Soon thereafter, in January 2014, the FDA approved Farxiga to treat Type-2 diabetes in adults when used in conjunction with diet and exercise. They allowed the drug into the marketplace with one caveat. Manufacturers Bristol-Myers Squibb and AstraZeneca had to conduct six post-market clinical studies, including a cardiovascular outcomes trial and a bladder cancer trial. The companies were also required to do studies on liver abnormalities, pediatric risks, urinary flow and pregnancy risks. Although finally approved to treat Type-2 diabetes in August 2014, Jardiance (empagliflozin) was originally denied FDA approval when initially submitted in March 2013. At that time, the FDA issued a letter referencing deficiencies at a Boehringer Ingelheim facility where empagliflozin would be manufactured and stated they needed to be resolved before the approval of the application. The FDA did not ask Boehringer to complete any new clinical trials to support the approval of the application. After less than one year on the market, the FDA issued a warning about the potential link between Jardiance and ketoacidosis. The approval of Invokamet, manufactured by Janssen Pharmaceuticals, also took place in August 2014. Invokamet is a combination of Invokana and Metformin hydrochloride, an older generation diabetes medication. It is intended to treat Type-2 diabetes in adults whose blood glucose is not adequately controlled by Metformin or Invokana Continue reading >>

T2 Diabetes

T2 Diabetes "pee Drug" Invokana Useful For Type 1 Too?

A little pee could go a long way in helping type 1s get their blood sugars in line. At least that's what researchers think about the new class of drugs known as SGLT-2 inhibitors, which are designed for use in people with type 2 but are also becoming a potential treatment for type 1s. Yes, these new sodium-glucose transporter inhibitors could provide an interesting therapy boost for type 1s, even though we aren't the tar get audience for them at this point. Research in very early stages is showing promise and could lead to more comprehensive clinical studies. All of this comes at a time when a growing class of SGLT-2 inhibitors is premiering, making a splash in the media with lots of pee-based headlines. The two on the market in the U.S. so far are Janssen's Invokana (officially Canagliflozin) that cleared the FDA in March 2013, and Farxiga (aka Dapagliflozin) made by Bristol Myers Squibb and FDA approved in January 2014. And there's at least one more coming from Eli Lilly, developing Empagliflozin that's yet to clear the FDA. Whatever the name, these drugs have a simple job: blocking glucose re-absorption in the kidney through increased urination, which leads to lower glucose levels. They also have the welcome side effect of weight loss, which most other diabetes drugs haven't offered (with the notable exception of Byetta). At the moment, only the once-daily pill Invokana is being researched for use with type 1 PWDs. Those who've seen this research in action say there's a lot to look forward to. Dr. Richard Jackson of Joslin Diabetes Center is one of a few key researchers who've been looking at this class of drugs for use in type 1s for the past year. He echoes what others say about the potential for smoothing out post-prandial blood sugars and offering weight loss ben Continue reading >>

Invokana Side Effects Center

Invokana Side Effects Center

Invokana (canagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor used to control blood sugar in people with type 2 diabetes mellitus, in addition to diet and exercise. Common side effects of Invokana include: urinary tract infections, increased urination, yeast infections, vaginal itching, thirst, constipation, nausea, fatigue, weakness, skin sensitivity to sunlight, hypersensitivity reactions (including skin redness, rash, itching, hives, and swelling), bone fractures, and kidney problems. The recommended starting dose of Invokana is 100 mg once daily, taken before the first meal of the day. Doses may be increased to 300 mg in patients who are able to tolerate Invokana at 100 mg doses. Invokana may interact with rifampin or digoxin. Tell your doctor all medications you use. Invokana should only be given to a pregnant woman if the benefit of the drug justifies the risk of harm to the fetus. Breastfeeding women should decide with their doctors whether to breastfeed or to discontinue taking Invokana. Our Invokana (canagliflozin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Continue reading >>

Diabetes Drug Invokana Found To Cause Amputations & Diabetic Ketoacidosis

Diabetes Drug Invokana Found To Cause Amputations & Diabetic Ketoacidosis

INVOKANA or canagliflozin is an oral drug administered to patients with type 2 diabetes over the last four years to reduce blood sugar glucose levels. The drug works as a sodium-glucose cotransporter 2 inhibitor, increasing the release of sugar into the urine. Other brand names of the drug include Invokamet and Invokamet XR. Since its release in 2013, many diabetic patients switched over to using INVOKANA from other diabetes medications. According to one company’s estimation, approximately 4.5 million INVOKANA prescriptions were filled in 2016 in the U.S. alone. However, in May 2017, the Food and Drug Administration (FDA) issued a black box warning, concluding that the drug caused an increased risk of leg and foot amputations, and required new warnings be placed on all drugs containing canagliflozin, describing the risks. Other known side effects include kidney failure, heart attacks, diabetic ketoacidosis, and related injuries. Trials & Side Effects: Amputations & Ketoacidosis The FDA knew of the diabetic ketoacidosis risk, and required that Johnson & Johnson add warnings to INVOKANA, highlighting this especially dangerous risk, in December 2015. Diabetic ketoacidosis can be fatal if left untreated. In June 2016, the company was required to add additional warnings concerning other kidney injuries, including the risk of acute kidney injuries. It was recently reported that many doctors are deciding to take their patients entirely off INVOKANA after the industry-sponsored trials found that the drug specifically doubled the risk of lower limb amputations. In the trial, approximately half of the amputations occurring were of toes, while the rest were at the ankle, across the foot, below the knee, or right above the knee. Some hospital pharmacies are also now keeping canag Continue reading >>

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